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510(k) Data Aggregation
K Number
K003386Manufacturer
Date Cleared
2000-12-28
(58 days)
Product Code
Regulation Number
892.1000Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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